CompletedNot Applicable

Transnasal Induction of Normothermia in Febrile Stroke Patients

United States30 participantsStarted 2018-01-16

Plain-language summary

The objective of this study is to evaluate safety and performance of the COOLSTAT® Transnasal Thermal Regulating Device in reducing temperature in a population of febrile subjects who meet the inclusion/exclusion criteria.

Who can participate

Age range18 Years – 95 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Admitted to the Neurosciences Critical Care Unit (NCCU).
✓. Patient has ischemic or hemorrhagic stroke, seizure, or metabolic encephalopathy.
✓. Patient is orally intubated or has tracheostomy tube and is mechanically ventilated.
✓. Planned stay in NCCU \> 24 hours.
✓. Must have informed consent from the patient or the legally authorized representative (LAR)

Exclusion criteria

✕. Age \< 18 years old or \> 95 years.
✕. Intubation is contraindicated.
✕. With a coagulopathy. INR above 1.5 or PTT above 45 seconds.
✕. Hemodynamic instability, including elevated SPB for \>5 minutes despite standard of care interventions (SPB ≥ 160 mmHg for intracerebral hemorrhagic stroke; SPB ≥ 220 mmHg for subarachnoid hemorrhagic stroke or ischemic stroke).
✕. History of cryoglobulinemia.
✕. History of sickle cell disease.
✕. History of serum cold agglutinin disease.
✕. Active/ongoing of nose bleeds.

What they're measuring

Cooling Performance

Timeframe: 4 hours

Trial details

NCT IDNCT03360656

SponsorCoolTech LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-04-22

Results submitted2023-05-25

View on ClinicalTrials.gov More Stroke, Ischemic trials